Bipolar Radiofrequency Ablation Plus Argon Beam Coagulator Ablation for Atrial Fibrillation
1 other identifier
interventional
200
1 country
1
Brief Summary
The objective of the study is to make up the technique blind spots of the bipolar radiofrequency ablation in the surgical treatment of atrial fibrillation with rheumatic heart disease by using argon beam coagulator. And to improve the rates of cardioversion of atrial fibrillation after surgery, to decrease the long-term recurrence rate of atrial fibrillation and to compare the early term and long term outcomes of bipolar radiofrequency ablation and bipolar radiofrequency plus argon beam coagulator ablation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jul 2015
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJanuary 27, 2017
July 1, 2016
2.8 years
April 8, 2015
January 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
electrocardiogram：rates of cardioversion of atrial fibrillation
The investigators plan to check the electrocardiogram of all the 200 individuals involved in our study 3 years after surgery to ensure the rate of cardioversion of atrial fibrillation
3 years after surgery
Secondary Outcomes (6)
surgery time
during surgery
cardiopulmonary bypass time
during surgery
long-term recurrence rate of atrial fibrillation
3 years
complication after surgery
3 years
radiofrequency ablation time
during surgery
- +1 more secondary outcomes
Study Arms (2)
Argon beam coagulator ablation group
EXPERIMENTALIn the bipolar left atrial radiofrequency ablation, when the linear ablation was performed through along the lower edge of interatrial groove incision up to the mitral annulus, there is a gap between the ends of the ablation line and the mitral annulus And in the bipolar right atrial radiofrequency ablation, when the linear ablation was performed along the lower edge of the coronary sinus ostium up to the inferoseptal commissure and through the vertical incision on anterior wall of the right atrium up to the tricuspid annulus. There also have gaps between ends of the ablation line and the tricuspid annulus. In the experimental group the investigators plan to use conventional bipolar radiofrequency ablation and use argon beam coagulator to ablate these gaps.
Bipolar radiofrequency ablation group
EXPERIMENTALOnly use conventional bipolar radiofrequency ablation and do not deal with these gaps.
Interventions
The investigators plan to use argon beam coagulator ablation plus bipolar radiofrequency ablation in the argon beam coagulator ablation group.
The investigators only use bipolar radiofrequency ablation in the left and right atrial radiofrequency ablation.
Argon beam coagulator（American，Valleylab）will be used in the argon beam coagulator ablation group
The investigators plan to use bipolar radiofrequency(AtricuteTM) in the bipolar radiofrequency group
Eligibility Criteria
You may qualify if:
- The patients got atrial fibrillation with rheumatic heart disease need surgical radiofrequency ablation treatment
You may not qualify if:
- left atrial diameter\>65mm，
- sick sinus syndrome，
- atrioventricular block，
- ventricular tachycardia，
- reoperation patients，
- implantation of permanent pacemaker，
- NYHA(New York Heart Association) class IV，
- Malignant tumor, or other serious diseases which life expectancy \< 1 year，
- Heating temperature above 38 degrees or active infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lin Chen
Chongqing, Chongqing Municipality, 400037, China
Related Publications (1)
[1] Hong L, Lin C, Yinbing X, et al. Early Efficacy Analysis of Biatrial Ablation versus Left and Simplified Right Atrial Ablation for Atrial Fibrillation Treatment in Patients with Rheumatic Heart Disease. Heart Lung Circ. 2015 [2] Hussein AA, Wazni OM, Harb S, Joseph L, Chamsi-Pasha M, Bhargava M,et al. Radiofrequency Ablation of Atrial Fibrillation in Patients With Mechanical Mitral Valve Prostheses. J Am Coll Cardio 2011;58:596-602 [3] PasicM, Bergs P, Muller P, et al. Intraoperative radiofrequencymaze ablation for trail fibrillation: the berlin modification [J]. Ann Thorac Surg,2001,72(5):1484-1490 [4] WilliamsM R, GarridoM, OzMC, et al. Alternative energy source for surgical atrial ablation [J].J Card Surg,2004,19(3):201-206 [5] Nitta T. Surgery for trail fibrillation: a worldwide review [J]. Semin Thorac Cardiovasc Surg, 2007, 19(1):3-8
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lin Chen
Department of Cardiovascular Surgery, Xinqiao Hospital, Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident surgeon in the Department of Cardiovascular Surgery of Xinqiao Hospital
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 22, 2015
Study Start
July 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
January 27, 2017
Record last verified: 2016-07